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Experimental subjects
Experimental subjects are people who participate in psychological experiments as subjects observed by the experimenter. With human subjects there are important ethical and methodological protocols to be observed. Human subject research includes experiments (formally known as interventional studies) and observational studies. Human subjects are commonly participants in research on basic biology, clinical medicine, psychology, and all other social sciences. Humans have been participants in research since the earliest studies. As research has become formalized the academic community has developed formal definitions of "human subject research", largely in response to abuses of human subjects. Definition of a human subject In biostatistics or psychological statistics, a research subject is any object or phenomenon that is observed for purposes of research. In survey research and opinion polling, the subject is often called a respondent. In the United States Federal Guidelines a human subject is a living individual about whom an investigator conducting research obtains 1) Data through intervention or interaction with the individual, or 2) Identifiable private information (32 CFR 219.102.f). History Middle Ages Systematic experimentation and quantification were introduced into the study of physiology in 1025, by the influential Persian Muslim physician, Avicenna (Ibn Sina), in The Law of Medicine (Al-qanun fi al-tibb).Katharine Park (March 1990). "Avicenna in Renaissance Italy: The Canon and Medical Teaching in Italian Universities after 1500 by Nancy G. Siraisi", The Journal of Modern History 62 (1), p. 169-170. He also introduced the use of biomedical research, clinical trials,David W. Tschanz, MSPH, PhD (August 2003). "Arab Roots of European Medicine", Heart Views 4''' (2). randomized controlled trials,Jonathan D. Eldredge (2003), "The Randomised Controlled Trial design: unrecognized opportunities for health sciences librarianship", Health Information and Libraries Journal '''20, p. 34–44 36.Bernard S. Bloom, Aurelia Retbi, Sandrine Dahan, Egon Jonsson (2000), "Evaluation Of Randomized Controlled Trials On Complementary And Alternative Medicine", International Journal of Technology Assessment in Health Care 16 (1), p. 13–21 19. drug tests and efficacy testsD. Craig Brater and Walter J. Daly (2000), "Clinical pharmacology in the Middle Ages: Principles that presage the 21st century", Clinical Pharmacology & Therapeutics 67 (5), p. 447-450 449.Walter J. Daly and D. Craig Brater (2000), "Medieval contributions to the search for truth in clinical medicine", Perspectives in Biology and Medicine 43 (4), p. 530–540 536, Johns Hopkins University Press. on human subjects. Human dissections were carried out by Ibn Zuhr (Avenzoar),Islamic medicine, Hutchinson Encyclopedia. who introduced the use of experimentation in surgery during the 12th century,Rabie E. Abdel-Halim (2005), "Contributions of Ibn Zuhr (Avenzoar) to the progress of surgery: A study and translations from his book Al-Taisir", Saudi Medical Journal 2005; Vol. 26 (9): 1333-1339.Rabie E. Abdel-Halim (2006), "Contributions of Muhadhdhab Al-Deen Al-Baghdadi to the progress of medicine and urology", Saudi Medical Journal 27 (11): 1631-1641. as well as Ibn TufailJon Mcginnis, Classical Arabic Philosophy: An Anthology of Sources, p. 284, Hackett Publishing Company, ISBN 0872208710. and Saladin's physician Ibn Jumay in the 12th century, Abd-el-latif in 1200,Emilie Savage-Smith (1996), "Medicine", pp. 951-2, in and Ibn al-Nafis in the 13th century.Dr. Sulaiman Oataya (1982), "Ibn ul Nafis has dissected the human body", Symposium on Ibn al-Nafis, Second International Conference on Islamic Medicine: Islamic Medical Organization, Kuwait (cf. Ibn ul-Nafis has Dissected the Human Body, Encyclopedia of Islamic World). Early Modern Times HSR experiments were recorded during vaccination trials in the 1700s. In these early trials, physicians used themselves or their slaves as test subjects. Experiments on others were often conducted without informing the subjects of dangers associated with such experiments. A famous example of such research were the Edward Jenner experiments, in which he first tested smallpox vaccines on his son and neighbourhood children. In an instance of self-experimentation, Johann Jorg swallowed 17 drugs in various doses to record their properties. Conversely, the famous scientist Louis Pasteur "agonized over treating humans," though he was confident of previous results obtained through extensive animal trials. He consented to treat a human only when he was convinced that the death of his first test subject, the child Joseph Meister, "appeared inevitable." (Rothman 1993) Early 20th Century In the 1900s, as the progress of medicine began to accelerate, the concept of the various codes of ethics of scientific disciplines changed dramatically, and the treatment of research subjects along with it. Walter Reed's well-known experiments to develop an inoculation for yellow fever led these advances. Reed's vaccine experiments were carefully scrutinized, however, unlike earlier trials. (Brady 1982) Modern Era The infamous cases of human subjects abuse in the 20th century was Nazi experimentation, an example of research involving prisoners which came to light in the Nuremberg Doctors' trial and led to the Nuremberg Code of ethical human subjects research conduct. Research in the second half of the 20th century has been characterized by increasing attempts to protect human subjects through national agencies, institutional ethical review boards, and informed consent. History of human subjects abuses Strict policies now exist when a human being is the subject of an experiment. These evolved over time after particularly horrid abuses (and even atrocities) on human subjects: such as research involving prisoners research on slaves and servants, and research on family members. In some notable cases, doctors have performed experiments on themselves when they have been unwilling to risk the well-being of others. This is known as self-experimentation. 20th Century Unit 731, a department of the Imperial Japanese Army located near Harbin (Manchukuo), experimented with prisoner vivisection, dismemberment, bacteria inoculation and induced epidemics on a very large scale from 1932 onward through the Second Sino-Japanese war. With the expansion of the empire during World War II, many other units were implemented in conquered cities such as Nanking (Unit 1644), Beijing (Unit 1855), Guangzhou (Unit 8604) and Singapore (Unit 9420). After the war, Supreme commander of occupation Douglas MacArthur gave immunity in the name of the United States to Ishii and all members of the units in exchange for all of the results. Hal Gold, Unit 731 Testimony, 2003, p. 109 The United States blocked Soviet access to this information. However, some unit members were judged by the Soviets during the Khabarovsk War Crime Trials. De-classified documents of the National Archives revealed that during the 1930s and 1940s, the British Army allegedly used hundreds of British and native British Indian Army soldiers as “guinea pigs” in their experiments to determine if mustard gas inflicted greater damage on Indian skin compared to British skin. It is unclear whether the trial subjects, some of whom were hospitalised by their injuries, were all volunteers.Report: Britain Tested Chemical Weapons on Indian Colonial Troops Voice of America 2 September, 2007Indian soldiers used as guinea pigs during British Raj September 2, 2007 The News, Internationl, PakistanWhen Indians were guinea pigs The Hindu Times September 2, 2007Indian Troops Were Part of WWII Gas Tests UPI September 1, 2007 Fort Detrick in Maryland was the headquarters of US biological warfare experiments. Operation Whitecoat involved the injection of infectious agents to observe their effects in human subjects.BBC NEWS | Programmes | File on 4 | Hidden history of US germ testing After World War II In Sweden, the Vipeholm experiments were conducted, where retarded test subjects were exposed to large amounts of sugar to induce dental caries. In the United Kingdom (voluntary) human experimentation at Porton Down in the 1950s, led to the death of Ronald Maddison. Pharmaceutical giant Pfizer came under fire in 2001 for allegedly testing meningitis drugs on African children.http://news.bbc.co.uk/1/hi/world/africa/1465532.stm In Israel, a former worker of Negev Nuclear Research Center filed lawsuit, claiming that employees of the Center were given drinks with uranium without medical supervision and without obtaining written consent. United States In 1940 in the United States, four hundred prisoners in Chicago were infected with malaria to study the effects of new and experimental drugs for the disease. Beginning in 1942, mustard gas experiments were conducted on 4,000 United States servicemen in order to study the effects on the human nervous system. These tests concluded in 1945. The CIA ran an extensive toxicology and chemical/biological warfare program in cooperation with the US military. The Edgewood Arsenal and US Army Medical Research Institute for Infectious Diseases at Fort Detrick in Maryland were the main headquarters for such studies. At such centres, the agency developed many toxins, incapacitants, mind-altering substances and carcinogens. Mind-control substances were studied to facilitate interrogation and toxins were used as weapons in assassination. One of the toxins that the CIA studied extensively was derived from red algae called dinoflagellate which produces the red tide. MKULTRA, Tuskegee syphilis experiment (The Public Health Service Syphilis Study), hepatitis experiments on children at Willowbrook State School, Jewish Chronic Disease Study (1963), San Antonio Contraception Study (1971), Tea Room Trade Study, Obedience to Authority Study (Milgram Study), dermatological experiments on prisoners at Holmesburg Prison in Philadelphia (see Hornblum 1998), and human radiation experiments. Surgical Research Herophilos, the "father of anatomy" and founder of the first medical school in Alexandria, was described by the church leader Tertullian as having performed surgery on at least 600 live prisoners. In recent times, the wartime programs of Nazi Dr. Josef Mengele, Shiro Ishii, founder of the Japanese military Unit 731, and Dr. Fukujiro Ishiyama at Kyushu Imperial University Hospital, conducted surgery on concentration camp prisoners in their respective countries during World War II. In November 2006, Doctor Akira Makino confessed to Kyodo news having performed surgery and amputations on condemned prisoners, including women and children in 1944 and 1945 while he was stationed on Mindanao.Japanese doctor admits POW abuse, http://news.bbc.co.uk/2/hi/americas/6185442.stm In 2007, Doctor Ken Yuasa testified to the Japan Times that he believes at least 1,000 persons working for the Shōwa regime, including surgeons, did surgical research in mainland China."I was afraid during my first vivisection, but the second time around, it was much easier. By the third time, I was willing to do it." Vivisectionnist recalls his day of reckoning, https://archive.is/20120604105237/search.japantimes.co.jp/cgi-bin/nn20071024w1.html The use of the term vivisection when referring to procedures performed on humans almost always implies a lack of consent. Human volunteers can consent to be subjects for invasive experiments which may involve, for example, the taking of tissue samples (biopsies), or other procedures which require surgery on the volunteer. These procedures must be approved by ethical review, and carried out in an approved manner that minimizes pain and long term health risks to the subject.http://www.health.vic.gov.au/ethics/downloads/module1f_march05.doc Despite this, the term is generally recognized as pejorative: one would never refer to life-saving surgery, for example, as "vivisection." Questionable Psychological Experiments Several experiments have been conducted on consenting volunteers whose ethical nature is now considered questionable. Following exposure of these experiments, rules regarding informed consent have been tightened. * The Milgram experiment, in which many subjects were shown they were capable of inflicting discomfort (by electric shock) on other humans if under orders to do so * The Stanford prison experiment, in which many participants became violent and abusive of each other. * The Monster Study that was conducted on orphans in 1939 in an attempt to induce stuttering. Ongoing Human Subject Abuse * North Korea: Alleged North Korean human experimentation Human Subjects Guidelines Declaration of Helsinki In 1964, the World Medical Association developed a code of research ethics that came to be known as the Declaration of Helsinki. It was a reinterpretation of the Nuremberg Code, with an eye to medical research with therapeutic intent. Subsequently, journal editors required that research be performed in accordance with the Declaration. This document set the stage for the implementation of the Institutional Review Board (IRB) process. (Shamoo & Irving 1993) Beecher Article In 1966, anaesthesiologist Dr. Henry K. Beecher wrote an article, "Ethics and Clinical Research," describing 22 examples of research studies with controversial ethics that had been conducted by reputable researchers and published in major journals. Beecher wrote, "Medicine is sound, and most progress is soundly attained..." He believed, however, that if unethical research were not prohibited it would "do great harm to medicine." Beecher provided estimates of the number of unethical studies and concluded "unethical or questionably ethical procedures are not uncommon." (Beecher 1966) Belmont Report The Public Health Service Syphilis Study was among the most influential in shaping public perceptions of research involving human subjects. When the press exposed the study, the US Congress appointed a panel that determined that the PHS Syphilis Study should be stopped immediately and that overseeing of human research was inadequate. The panel recommended that federal regulations be designed and implemented to protect human research subjects in the future. Subsequently, the National Research Act of 1974 led to regulations now referred to as the "common rule," a group of similar requirements that cover the various forms of clinical research. In 1974, the United States Congress authorised the formation of the National Commission for the Protection of Human Subjects in Biomedical and Behavioral Research, known to most people in research ethics as the National Commission. Congress charged the National Commission with the task of identifying the basic ethical principles that affect the decision to use, or to not use, human research subjects. To accomplish this task, the National Commission looked at writings and discussions that had taken place to date and asked, "What are the basic ethical principles that are used to judge the ethics of human subject research?" Congress also asked the National Commission to develop guidelines to assure that human research is conducted in accordance with those principles. In 1979, the National Commission met and published the Belmont Report. The Belmont Report is required reading for everyone involved in human experimentation. The Belmont Report identifies three basic ethical principles that underlie human experimentation. These principles are commonly called the Belmont Principles. The Belmont Principles include: * Respect for persons * Beneficence * Justice CIOMS The Council for International Organizations of Medical Sciences (CIOMS) has written an International Ethical Guidelines for Biomedical Research Involving Human Subjects. APA Ethics Code The American Psychological Association (APA) has a documented ethics code pertaining to the practice of Psychology and associated research. This document contains great guidelines for the use of deception in research. For members of the APA, these are hard requirements levied against their membership. They are also requirements for any research project conducted, funded, or managed by the APA. Requirements and Guidelines for US Federal Research The following policies codify requirements that must be followed for any research conducted or supported by the US Federal Government. Common Rule This is the US codifitation of regulated policy based on the guidelines of the Belmont Report. It combines and supersedes previous disparate regulatory codes. ;45 CFR 46 :Title 45 Code of Federal Regulations, Part 46 (45 CFR 46) is the primary set of Federal regulations regarding the protection of human subjects in research and is often referred to as the Common Rule. It defines the laws, criteria for exemption, as well as definition and formulation of Institutional Review Boards (IRBs). Some Government agencies (e.g., DoD, FDA, etc.) have established their own implementation of this code that supersedes portions or all of 45 CFR 46. ;32 CFR 219 :This is the Department of Defense (DoD) implementation of 45 CFR 46, Subpart A. Subparts B, C, and D of 45 CFR 46 still apply to DoD supported research. It differs from 45 CFR 46 in the criteria for exemptions. ;21 CFR 50 :This is the implementation of the Common Rule by the Food & Drug Administration (FDA). It applies to research associated with the development of any food, drug, or medical device. US Department of Defense Research ;DoD Directive 3216.02 :This document defines additional requirements for HSR supported by the Department of Defense. ;10 USC 980 :Title 10, United States Code, Subtitle A, Part II, Chapter 49, Section 980 (10 USC 980) addresses the limitations on use of humans as experimental subjects. It basically states that funds cannot be deployed prior to obtaining informed consent. Scope of Guidelines Just because a project involves the use of human participants does not mean it constitutes human subject research. The activities must meet the definition of research, and the use of the human participants must meet the definition of human subjects. The definitions are written as such to include situations where the human is the subject of the experiment, their environment is manipulated by the researchers, and data regarding their responses are collected. If the project does not meet the definition of Human Subject Research, then the requirements do not apply, and the project does not require an IRB review or informed consent. However, it is best to have an IRB make this determination and document the decision. If a project is defined as Human Subject Research, it may still be considered Exempt. This generally means that the project is minimal risk, and the requirements do not apply. The protocol for the project must meet one of the exempt categories defined in the Common Rule. By definition then, an IRB does not need to perform a full review on the project, and informed consent is not required. However, again, an IRB needs to make this determination and document the decision. In these situations, the guidelines in the Belmont Report should still be followed since it is still Human Subject Research. US Federal Terminology ;Engaged :An institution is engaged in human subjects research when its employees or agents either: #intervene or interact with living individuals for research purposes; or #obtain individually identifiable private information for research purposes (32 CFR 219.102.d-f). ;Exempt :Not subject to HSU policies because it meets one or more of the exemption criteria defined in 32 CFR 219.101.b. ;Human Subject :A living individual about whom an investigator conducting research obtains: #Data through intervention or interaction with the individual, or #Identifiable private information (32 CFR 219.102.f). ;Interaction :Communication or interpersonal contact between investigator and subject (32 CFR 219.102.f). ;Intervention :Physical procedures by which data are gathered as well as manipulations of the subject or the subject’s environment that are performed for research purposes (32 CFR 219.102.f). ;Minimal Risk :The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests (32 CFR 219.102.i). ;Private Information :Individually identifiable information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (32 CFR 219.102.f). ;Research : A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge (32 CFR 219.102.d). See also *Animal testing *Animal testing on non-human primates *Debriefing (experimental) *Experimental attrition *Experiment controls *Experimental ethics *Experiment volunteers References * Beecher, Henry K. "Ethics And Clinical Research." The New England Journal of Medicine. Vol 274 No. 24, June 16, 1966, 1354 - 1360 * Brady, Joseph V. and Jonsen, Albert R. "The Evolution of Regulatory Influences on Research with Human Subjects." Human Subjects Research - A Handbook for Institutional Review Boards. Ed. Greenwald, Robert A. et al. New York: Plenum Press, 1982. 3 - 18 * * Mitscherlich, Alexander and Mielke, Fred. "Epilogue: Seven Were Hanged." Ed. Annas, George J and Grodin, Michael A. The Nazi Doctors And The Nuremberg Code - Human Rights in Human Experimentation. New York: Oxford University Press, 1992. 105 - 107 * * Rothman, David J. "Ethics and Human Experimentation: Henry Beecher Revisited." The New England Journal of Medicine. Vol. 317, No. 19, Nov.5, 1987 - Public Responsibility in Medicine and Research, Boston, April 1 - 2, 1993 * Shamoo, Adil E. and Irving, Dianne N. "Accountability in Research." 1993 in press - Public Responsibility in M Further reading * Goliszek, Andrew. In the Name of Science: A History of Secret Programs, Medical Research, and Human Experimentation, St. Martin's Press 2003, ISBN 0-312-30356-4 *Hornblum, Allen. Acres of Skin: Human Experiments at Holmesburg Prison: A True Story of Abuse and Exploitation in the Name of Medical Science. Routledge, 1998. * Kevorkian, Jack: A brief history of experimentation on condemned and executed humans. JAMA 77 (1985) pp.215-226 * Lederer, Susan: Subjected to science. Human experimentation in America before the Second World War Baltimore, Maryland: Johns Hopkins University Press 1995 * Moreno, Jonathan D. Undue Risk: Secret State Experiments on Humans. W H Freeman 1999, Routledge 2001. * Welsome, Eileen. The Plutonium Files: America's Secret Medical Experiments in the Cold War. Dell Publishing (Random House), 1999. category:Experimentation